FDA 510(k)

퓨전 세포학 브러시, 시토맥스 II 더블 루멘 세포학 브러시

K-번호: K192908 · 2019-11-14

결정일2019-11-14

제품 코드FDX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) number K192908. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K192908.

When did Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes receive FDA 510(k) clearance?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes received FDA 510(k) clearance on 2019-11-14, under 510(k) number K192908.

Who is the listed applicant for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is FDX.

Wilson-Cook Medical, Inc.를 신청인으로 등재한 기타 기록

K253302헤모스프레이 엔도스코픽 헴스타트 (HEMO-[X])K243568테슬라 투폴러 스플린트로미터; 테슬라 비시어드 아크티브 코르드 K213356엔튜트 PEG, 엔튜트 PEGJ K212323인스팅크 플러스 내시경 클리핑 장치 K201322엔튜� 나시널 제주널 영양선 K200972헴스프레이 내시경 혈막제제

32개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.